Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Comphya Inc.
Summary
The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.
Eligibility
- Age range
- 30–75 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery; * Cancer stage T1c and T2a; * Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease; * IIEF-15 erectile function domain score equal to or greater than 26; * Men interested in minimizing the effect of radical prostatectomy on erectile function; * Ability to read and understand patient information materials and willingness to sign a written informed consent. Exclusion…
Interventions
- DeviceActivation of pro-erectile nerves within the pelvic plexus
The study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function.
Location
- Johns Hopkins HospitalBaltimore, Maryland